Biotech Buildup

Taking the mystery out of biotech: Local companies explain their sophisticated science in plain English (really).

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If you ever want to be humbled, truly humbled, attend a lecture by Dr. James Thomson, the UW-Madison cell biologist who cultivated the first line of human embryonic stem cells. Not only will you be introduced to what seems like a foreign language, you will gain a keener understanding of the sophisticated science being developed in Madison’s biotechnology business community, an industry that Thomson is part of as one of the scientific founders of Cellular Dynamics International.

In our annual feature on Madison’s biotechnology sector, IB’s intent is not to blind you with science, but present a plain-English look at how local companies are developing both science and industry, and hopefully take some of the mystery out of what biotech companies do.

According to Russell Smestad, president of Stratatech, a Madison-based company that is developing therapeutic skin substitutes to treat severe burns and diabetic ulcers, the local biotechnology industry is comprised of about 160 companies, and one-fourth of them are engaged in developing new medicines or drugs.

In shining a light on their emerging contributions to medicine and health care, IB looks at a local company that’s bio-marking its territory in the fight against autism and cancer, another that is developing hard-nosed proteins that can help researchers in extreme conditions, and a research tool company operating in a community where, thanks to a comparative lack of venture capital funding, such toolmakers are more prevalent.

We also delve into the innovative and expanding product-development efforts of the aforementioned Stratatech, profile a biotech start up that’s doing battle with tuberculosis in the animal health market, and speak to a couple of accountants who are sounding an alarm for biotech companies that might be unaware that a new medical device tax also applies to certain biomedical products.

Stemming disease

You might say Stemina Biomarker Discovery is the very definition of a disease-fighting company. When CEO Beth Donley explains her mission, she includes definitions for metabolomics, the study of metabolism, and biomarkers, the small molecules in blood and urine that help measure the severity of a disease state.

Then come her product explanations. Stemina’s cell-based platforms include the devTOX assay, a diagnostic used to prevent drug-induced birth defects, and the cardioTOX assay, a tool that predicts the cardiotoxicity of drug therapies. Both reside on the drug screening and toxicology side of Stemina, where the business receives new compounds from drug companies, large agri-chemical companies, or the federal government, and doses either human embryonic stem cells in the case of devTOX, or cardiomyocytes (cardiac muscle cells) in the case of cardioTOX, to determine whether a compound is likely to cause birth defects or cardiotoxicity.

Another side of the business focuses on biomarker discovery. Stemina is attempting to build a test for diagnosing autism using blood samples, which would be a welcome alternative to the existing diagnostic process, a behavioral scoring system in which most children are not diagnosed until age 4-1/2. Stemina is working to diagnose autism earlier so that therapies can be applied earlier, and also to determine whether different interventions make sense for different patients.

“The goal is to identify new targets for potential therapies, so we may have classes of compounds that could help ameliorate symptoms that we’re not aware of because we don’t understand the biochemistry of the disease very well,” Donley said.

Stemina is involved in its first clinical study of blood from autistic patients at the Mind Institute at the University of California-Davis. If that study produces the desired results, the next step will be to establish a Clinical Laboratory Improvement Amendment, or CLIA lab, at Stemina. Under this regulatory exception, a test developed within a company, and delivered by the company, does not have to go through the usual regulatory approval process.

“We would get a CLIA lab certified at Stemina,” Donley explained, “and we’d enroll patients to validate the biomarkers we discover in early clinical work so that a practitioner at the [UW] Waisman Center or the Mind Institute would conclude the test is definitive enough and be willing to request it.”